Print This Page

FMEA

Custom Search

Quality Pro's Toolbox $9.99 

FMEA Part 1


Purpose

Failure Modes & Effects Analysis (FMEA) is used to assure, in an analytical and systematic manner, that potential process or product failure modes, their associated causes, and the potential customer effects of the failures, have been considered and addressed.

LOW COST PAPERLESS (WEB BASED) QMS


Anatomy

FMEA

Reference: Potential Failure Mode and Effects Analysis Reference Manual – Chrysler, Ford and General Motors

Terminology

A. Process or Product Name – Description of Process or Product being analyzed.

B. Responsible – Name of Process Owner.

C. Prepared By - Name of Agent coordinating FMEA study.

D. FMEA Date – Dates of Initial and subsequent FMEA Revisions.

E. Process Step/Part Number – Description of individual item being analyzed.

F. Potential Failure Mode – Description of how the process could potentially fail to meet the process requirements and/or design intent, i.e. a description of a non-conformance at that specific process step.

G. Potential Failure Effects – Description of the effects of the Failure Mode upon the customer, i.e. what the next user of the process or product would experience or notice.

H. SEV (Severity) – An assessment of the seriousness of the effect of the potential failure mode upon the customer.


Major Considerations

A Failure Mode and Effects Analysis should be updated after each change introduced to the process. This means that this analysis is never over, unless the process is completely withdrawn.
Criteria can be adapted to the specific situation

Application Cookbook

1. Identify the form by entering the basic information from the analysis.

2. List the process steps (only those chosen from the Cause and Effect Matrix).

3. List all potential failure types for each process step (for example, in a Brainstorming session).

4. List the potential effects for each failure type.

5. Establish the severity rate of each effect.

FMEA - Severity Criteria Rating

10 Hazardous Without Warning
9 Hazardous With Warning
8 Very High
7 High
6 Moderate
5 Low
4 Very Low
3 Minor
2 Very Minor
1 None

FMEA Part 2


Purpose

To assure, in an analytical and systematic manner, that potential process or product failure modes, their associated causes, and the potential customer effects of the failures, have been considered and addressed

Anatomy

FMEA Instructions

Reference: Potential Failure Mode and Effects Analysis Reference Manual – Chrysler, Ford and General Motors

Terminology

A. Potential Causes – Description of how the failure could occur, described in terms of something that can be corrected or controlled.

B. OCC (Occurrence) – Description of how frequently the specific failure cause is expected to occur, ranked on a scale of 1 to 10 as per the table below.

C. Current Controls – Description of process controls that either prevent, to the extent possible, the failure mode from occurring, or detect the failure mode should it occur.

D. DET (Detection) – An assessment of the probability that the current controls will detect the potential cause, or the subsequent failure mode.

E. RPN (Risk Priority Number) – The product of the Severity, Occurrence, and Detection Rankings i.e. RPN = SEV * OCC * DET.


Major Considerations

A Failure Mode and Effects Analysis should be updated after each change introduced to the manufacturing or assembly process. This means that this analysis is never over, unless the process is completely withdrawn from production.

Application Cookbook

1. Determine the possible causes of the failures identified (for example, in a Brainstorming session).
2. Assign a level of occurrence (frequency of the failure).
3. Identify the control methods for each potential cause listed.
4. Establish the level of detection that describes the probability that the failure will be detected by the existing controls.
5. Calculate the Risk Priority Number: RPN = level of severity x level of occurrence x level of detection.

FMEA - Occurence Detection Rating

10 1 in 2 Very High 10 Absolute Uncertainty
9 1 in 3 Very High 9 Very Remote
8 1 in 8 High 8 Remote
7 1 in 20 High 7 Very Low
6 1 in 80 Moderate 6 Low
5 1 in 400 Moderate 5 Moderate
4 1 in 2,000 Moderate 4 Moderately High
3 1 in 15,000 Low 3 High
2 1 in 150,000 Low 2 Very High
1 1 in 1,500,000 Remote 1 Almost Certain

FMEA - Detection Rating

10 Absolute Uncertainty
9 Very Remote
8 Remote
7 Very Low
6 Low
5 Moderate
4 Moderately High
3 High
2 Very High
1 Almost Certain

FMEA Part 3


Purpose

To assure, in an analytical and systematic manner, that potential process or product failure modes, their associated causes, and the potential customer effects of the failures, have been considered and addressed

Anatomy

how to conduct a fmea

Reference: Potential Failure Mode and Effects Analysis Reference Manual

Terminology

A. Actions Recommended – Actions to reduce any or all of the Occurrence, Severity or Detection rankings.

B. Responsibility – Person or group responsible for the Recommended Action.

C. Actions Taken – Brief description of actual action and effective date.

D. New SEVERITY Rating after corrective action.

E. New OCCURENCE Rating after corrective action.

F. New DETECTION Rating after corrective action.

G. Resulting new RPN after corrective action.


Major Considerations

A Failure Modes and Effects Analysis should be updated after each change introduced to the manufacturing or assembly process. This means that this analysis is never over, unless the process is completely withdrawn from production.

Application Cookbook

1. Recommend corrective measures.

2. Identify the persons or department responsible for implementing corrective measures and a performance date for the action plan.

3. Follow up the recommendations by indicating what measures have been taken.

4. Recalculate the Risk Priority Numbers after implementing the corrective measures.

From FMEA to Six Sigma Tools.

WORKFORCE TRAINING SOLUTIONS

Convert PDF
QA Pro's Wanted

Recent Articles

  1. Free Six Sigma Tools and Training.

    Aug 12, 14 09:12 PM

    "MASSIVE TOOLBOX" of 100's of Free Six Sigma Tools, Free Quality Improvement Tools, and Free Training, Procedures and Forms.

    Read More

  2. Alternative and Null Hypothesis

    Jul 18, 14 07:35 PM

    Hypothesis testing for means, a quick overview.

    Read More

  3. Quality Improvement Store

    Jun 28, 14 11:26 AM

    Shop Quality At The Quality Improvement Store

    Read More